510(k) Predicate Finder
Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.
Let the assistant find your predicates
Describe your device and the Research Assistant searches 510(k)s, compares intended use, and drafts a predicate shortlist — with citations.
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Medevac Use Oxygen Generator
Anesthesiology
The MEDEVAC Use Oxygen Generator (product code OLF) is a Class 2 device regulated under 21 CFR 868.5440 in the Anesthesiology specialty (AN), cleared through the 510(k) pathway. It is intended to release oxygen for respiratory therapy, using either a chemical reaction or physical means such as a molecular sieve, and is designed exclusively for use aboard MEDEVAC helicopters where it is affixed to the aircraft. The device carries a life-sustaining or life-supporting flag, reflecting its critical role in patient care during aeromedical evacuation.
510(k) Clearances
1 matchesWhat is a Predicate Device?
A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.
Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.
Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.